In this white paper, Robert Smith provides a deep review of the EU advanced therapy medicinal products GMP guidance that came into force on 22 May 2018. Robert outlines what is included in the guidance and takes a closer look at some of the important sections and what they mean to the manufacture of ATMPs
On 22 November 2017, the EU Commission adopted the Guidelines on Good Manufacturing Practice specific to advanced therapy medicinal products (ATMPs), as Part IV of EudraLex Volume 4.
When these guidlenes were first drafted, most manufacturers of ATMPs were critical of the guidelines being a separate guidance document rather than being an annex to the existing guidelines in EudraLex Volume 4.
There were also criticisms from smaller academic and hospital units that the new guidelines place too much burden on these units in their rigid application of industrial type GMPs, which they argued was not practicable to these highly innovative products.
Concern was also expressed that as the initial draft stood, the innovative research that was going on with ATMPs would be hindered in the EU.